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Oleogel-S10 in Wound Healing of Inherited Epidermolysis Bullosa (BEB-10)

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ClinicalTrials.gov Identifier: NCT01294241
Recruitment Status : Completed
First Posted : February 11, 2011
Results First Posted : January 23, 2018
Last Update Posted : January 23, 2018
Sponsor:
Information provided by (Responsible Party):
Amryt Pharma ( Birken AG )

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Inherited Epidermolysis Bullosa
Interventions Drug: Oleogel-S10
Device: Mepilex® soft silicone faced polyurethane foam dressing
Enrollment 10
Recruitment Details Participants were enrolled from 03 Nov 2010 to 14 Jun 2011 at 1 center (University Medical Center Freiburg) in 1 country (Germany).
Pre-assignment Details 12 wounds in 10 participants (2 cycles of treatment in 2 participants) were treated with study medication. The reepithelialization was compared intra-individually in either 2 halves of an Epidermolysis bullosa (EB) wound ≥10 cm2 and ≤200 cm2 in size or in 2 EB wounds ≥5 cm2 in size, i.e. the total number of participants was 10 in the overall study.
Arm/Group Title All Study Participants
Hide Arm/Group Description One (half of an) EB wound ≥10 cm2 and ≤200 cm2 in size or 1 EB wound ≥5 cm2 in size was treated with Oleogel-S10 and non-adhesive wound dressing. The other wound (half) was covered with a non-adhesive wound dressing only (Mepilex®) as control (intra-individual comparison).
Period Title: Overall Study
Number of participants Number of units (Wounds)
Started 10 12
Completed 10 12
Not Completed 0 0
Arm/Group Title All Study Participants
Hide Arm/Group Description One (half of an) EB wound ≥10 cm2 and ≤200 cm2 in size or 1 EB wound ≥5 cm2 in size was treated with Oleogel-S10 and non-adhesive wound dressing. The other wound (half) was covered with a non-adhesive wound dressing only (Mepilex®) as control.
Overall Number of Baseline Participants 10
Overall Number of Units Analyzed
Type of Units Analyzed: Wounds
12
Hide Baseline Analysis Population Description
As 2 participants received 2 cycles of treatment each, 12 wounds were treated with study medication.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
<=18 years
5
  50.0%
Between 18 and 65 years
5
  50.0%
>=65 years
0
   0.0%
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 10 participants
20
(6 to 48)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
Female
3
  30.0%
Male
7
  70.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Germany Number Analyzed 10 participants
10
1.Primary Outcome
Title Intra-individual Difference in Reepithelialization of Wound (Halves) at Day 14 in ‘Recent Wounds’ or Day 28 in ‘Chronic Wounds’
Hide Description The primary end point was the progress of reepithelialization from baseline to either Day 14 (‘recent wounds’) or Day 28 (‘chronic wounds’) of the EB wound (half) treated with Oleogel-S10 and non-adhesive wound dressing (Mepilex®) intra-individually compared to the other wound (half) covered with non-adhesive wound dressing only (intra-individual comparison). Two independent experts were blind to treatment and assessed efficacy based on chronological series of cropped and coded photographs by wound (half) that were taken before start of treatment, during wound dressing changes and at the end of treatment on Day 14/Day 28. They evaluated each series and decided whether 1 wound (half) reepithelialized faster than the other (‘winner’), or whether there was no difference in reepithelialization.
Time Frame 14 days for 'recent wounds', 28 days for 'chronic wounds'
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
12 wounds in 10 participants (intra-individual comparison, 2 cycles of treatment in 2 participants) were evaluated by assessors that were blind to treatment. 'Undecided' wounds that were either evaluated controversially (n=2) or as being equal (n=2) were excluded from the analysis of the primary efficacy variable.
Arm/Group Title All Study Participants
Hide Arm/Group Description:
Intra-individual comparison of two treatments: One half of an EB wound ≥10 cm2 and ≤200 cm2 in size or 1 EB wound ≥5 cm2 in size was treated with Oleogel-S10 and non-adhesive wound dressing. The other wound (half) was covered with a non-adhesive wound dressing only (Mepilex®) as standard of care control.
Overall Number of Participants Analyzed 10
Overall Number of Units Analyzed
Type of Units Analyzed: Wounds
8
Count of Units
Unit of Measure: Wounds
Faster healing of wound treated with Oleogel-S10
8
 100.0%
Faster healing of wound treated with dressing
0
   0.0%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection All Study Participants
Comments The intra-individual difference in reepithelialization of wound (halves) was tested using a two-sided exact binomial test. The test was performed at a significance level of 5% for the null-hypothesis of no difference δ = 0 against the hypotheses δ ≠ 0: H0: δ = 0 H1: δ ≠ 0
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.008
Comments Post-hoc superiority analysis: Wounds that were either evaluated controversially (n=2) or as being equal (n=2) were excluded from the analysis of the primary efficacy variable.
Method Two-sided exact binomial test
Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Wound Epithelialization at Day 7±1
Hide Description The secondary endpoint was the intra-individual difference in median percentage of wound epithelialization at Day 7±1. Sizes of wound areas were measured using a digital wound evaluation program from the EB Center at the Department of Dermatology, University Medical Center Freiburg.
Time Frame Day 7±1
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
As 2 participants received 2 cycles of treatment each, 12 wounds were treated with study medication.
Arm/Group Title Oleogel-S10 and Non-adhesive Wound Dressing Non-adhesive Wound Dressing Only
Hide Arm/Group Description:
One half of an EB wound ≥10 cm2 and ≤200 cm2 in size or 1 EB wound ≥5 cm2 in size was treated with Oleogel-S10 and non-adhesive wound dressing.
The other half of an EB wound ≥10 cm2 and ≤200 cm2 in size or 1 EB wound ≥5 cm2 in size was treated with non-adhesive wound Dressing only as control.
Overall Number of Participants Analyzed 10 10
Overall Number of Units Analyzed
Type of Units Analyzed: Wounds/wound halves
12 12
Median (Full Range)
Unit of Measure: Percentage of wound epithelialization
69.7
(17.3 to 90.4)
57.4
(10.0 to 81.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Oleogel-S10 and Non-adhesive Wound Dressing
Comments The intra-individual difference in median percentage of wound epithelialization was tested using a two-sided Wilcoxon test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.21
Comments Post-hoc superiority analysis
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
3.Secondary Outcome
Title Percentage of Wound Epithelialization at Day 14±1
Hide Description The secondary endpoint was the intra-individual difference in median percentage of wound epithelialization at Day 14±1. Sizes of wound areas were measured using a digital wound evaluation program from the EB Center at the Department of Dermatology, University Medical Center Freiburg.
Time Frame Day 14±1
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
As 2 participants received 2 cycles of treatment each, 12 wounds were treated with study medication.
Arm/Group Title Oleogel-S10 and Non-adhesive Wound Dressing Non-adhesive Wound Dressing Only
Hide Arm/Group Description:
One half of an EB wound ≥10 cm2 and ≤200 cm2 in size or 1 EB wound ≥5 cm2 in size was treated with Oleogel-S10 and non-adhesive wound dressing.
The other half of an EB wound ≥10 cm2 and ≤200 cm2 in size or 1 EB wound ≥5 cm2 in size was treated with non-adhesive wound Dressing only as control.
Overall Number of Participants Analyzed 10 10
Overall Number of Units Analyzed
Type of Units Analyzed: Wounds/wound halves
12 12
Median (Full Range)
Unit of Measure: Percentage of wound epithelialization
87.7
(2.7 to 100.0)
79.2
(0.0 to 98.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Oleogel-S10 and Non-adhesive Wound Dressing
Comments The intra-individual difference in median percentage of wound epithelialization was tested using a two-sided Wilcoxon test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.33
Comments Post-hoc superiority analysis
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Time Frame Adverse events were recorded from start of study treatment (Day 0) to completion of study treatment (Day 14/Day 28), i.e. for a period of up to 2 or 4 weeks.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Safety Population
Hide Arm/Group Description All participants who received at least 1 dose of Oleogel-S10 were included in the safety population. All adverse events were reported for all study participants. Localized adverse events were not separately reported by intervention.
All-Cause Mortality
Safety Population
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Safety Population
Affected / at Risk (%) # Events
Total   0/10 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Safety Population
Affected / at Risk (%) # Events
Total   6/10 (60.00%)    
Infections and infestations   
Flu-like syndrome * 1  1/10 (10.00%)  1
Skin and subcutaneous tissue disorders   
Wound area increased due to trauma/wound dressing change * 1  5/10 (50.00%)  9
Wound infection * 1  1/10 (10.00%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (10.0)
Small sample size, subjects with dystrophic Epidermolysis bullosa only, difficult wound size analysis at fixed study days due to several episodes of re-trauma in both intervention and control wounds
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Head of Clinical Development
Organization: Amryt Pharma
Phone: +353 1 669 4606
Responsible Party: Amryt Pharma ( Birken AG )
ClinicalTrials.gov Identifier: NCT01294241     History of Changes
Other Study ID Numbers: BEB-10
First Submitted: October 27, 2010
First Posted: February 11, 2011
Results First Submitted: October 22, 2016
Results First Posted: January 23, 2018
Last Update Posted: January 23, 2018